Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a man or woman aged 18 or older
• You have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC), confirmed by a biopsy or scan using recognised medical guidelines
• Your liver cancer has spread, cannot be surgically removed, or is considered advanced, as decided by a specialist team
• Your cancer has continued to grow or spread while you were receiving a standard approved first-line immunotherapy treatment
• Your doctor has decided it is appropriate for you to continue that same immunotherapy treatment despite the cancer progressing
• Your liver is still functioning reasonably well, as measured by a standard liver scoring system called Child-Pugh A (checked within 7 days before joining)
• You are generally well enough to carry out daily activities, with little or no limitation (measured by a standard scale scored 0 or 1)
• Your blood counts and kidney function are within acceptable levels (confirm with trial site for exact values)
• Your cancer can be measured on scans using standard methods (RECIST 1.1)
• You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

• Your cancer actually shrank or responded well to your current immunotherapy treatment
• You have had serious side effects (grade 3 or higher) from your current immunotherapy, or have ongoing side effects above a mild level
• More than half of your liver is affected by the cancer
• The cancer has grown into major blood vessels near the liver (with some exceptions — confirm with trial site)
• You are pregnant, breastfeeding, or could become pregnant and are not using adequate contraception
• You are under a legal protection order or have restrictions on your personal freedom (confirm with trial site)
• You have a history of a serious autoimmune disease (where the immune system attacks the body)
• You have a lung condition called interstitial lung disease
• You have a chronic hepatitis B infection that is not well controlled or not being treated with antiviral medication
• You have HIV infection
• You are taking medications that suppress your immune system, including steroid medicines above a certain dose
• You have had a liver transplant, or are planning to have one
• You have difficulty swallowing
• You have had major surgery or a serious injury within the last 4 weeks
• You have taken part in another clinical trial with an experimental treatment within the last 3 months
• You have had a serious infection requiring treatment within the last 30 days
• You have had a severe allergic reaction to the study drug (EXL01), its ingredients, or soy-based products
• You have had a severe allergic reaction to certain types of laboratory-produced antibody treatments (confirm with trial site)
• You have an active inflammatory bowel condition (such as Crohn's disease or ulcerative colitis), coeliac disease, or uncontrolled diarrhoea from a gut condition
• You are currently taking or planning to take probiotic supplements during the trial
• You have specific health conditions that mean you cannot safely continue your current immunotherapy — these vary depending on which immunotherapy you are receiving and include things like recent blood clots, uncontrolled high blood pressure, heart disease, or previous allergic reactions to those specific medicines (confirm with trial site for the full list)

Important: Always verify eligibility with the trial site directly before applying.